Featured Products
We have picked up a number of products that are of interest.
FDA QSR
【FDA CFR 820 QSR Compliance】Traceability Provision and Procedure
¥400
Compliance with GMP ordinances
【Compliance with GMP ordinances】Collection of computerized system management procedures (SOPs)
¥3,000
FDA QSR
【FDA CFR 820 QSR Compliance】Process Design Procedure and Forms
¥300
FDA QSR
【FDA CFR 820 QSR Compliance】Nonconforming Product Provision, Procedure, and Forms
¥500
FDA QSR
【FDA CFR 820 QSR Compliance】Design Change Provision, Procedure, and Forms
¥500
FDA CFR 803
【FDA CFR 803 Compliance】MDR Procedure
¥200
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Useful Information
Very useful information that is not considered to be free is posted in a one-point format!
医療機器の設計・開発・申請における規制要件入門 ～品質、有効性及び安全性の確保～ 4講 医療機器と安全性
Guidance for Industry, Third Parties and Food and Drug Administration Staff – Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program （FDA 20123.19）
ICH Q7 原薬GMPのガイドライン（平成13年11月 2 日、薬発第1200号）